BRUKINSA (Beigene Aus Pty Ltd)
Product name
BRUKINSA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
178 (255 working days)
Active ingredients
zanubrutinib
Registration type
EOI
Indication
Chronic Lymphocytic Leukaemia (CLL)/Small Lymphocytic Lymphoma (SLL)
BRUKINSA is indicated as monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), including patients with deletion 17p and/or TP53 mutation.